For many biopharma companies, managing regulatory information can be incredibly difficult because of complex data standards, an increasing volume of data, and the presence of both structured and unstructured information. Additionally, regulatory information management (RIM) has evolved rapidly over the past decade from simple product registration tracking to a more holistic process that involves comprehensive decision-making. In response, companies have turned to outsourcing partners to help distribute the workload, but that introduces a new set of challenges and chances.
Join this webinar co-hosted by Veeva and Pharmalex to learn how a unified RIM solution can help companies streamline regulatory processes and make those partnerships more effective and powerful. We’ll focus on high quality document and data standards, worldwide accessible systems, and efficient processes for capturing and managing information in a seamless and secure manner across different sources. In addition, we’ll share a case study from Alnylam and our best practices for delivering high-quality, impactful implementations with an emphasis on measuring success in the short and long term.
Director Strategy Vault RIM
Katrin is Director of Strategy for Vault RIM solutions, focusing on the European market at Veeva Systems. Katrin is an expert in regulatory strategy and business processes, being around in the life sciences industry for over twenty years. First embarking on her career in the regulatory departments of Janssen Pharmaceutica and Pfizer, Katrin moved on to provide regulated content management consultancy as a senior consultant at PwC and IBM. Prior to joining Veeva, Katrin founded, established and successfully sold Comply Services, a company that provided consulting and services within Regulatory Affairs, Regulatory Operations and Quality.
Director Regulatory Operations, PharmaLex
Jennie is Director of Regulatory Operations, focusing on Regulatory Systems Governance at PharmaLex. Jennie has worked within the industry for over 20 years, with a focus on systems and processes to support the regulatory affairs business. The majority of her experience has been in roles at Hospira and Allergan but she has also worked for software vendors ISI (now DXC Technology) and IQVIA. Jennie has a wealth of experience including RIM System implementation, business process review and improvement, regulatory intelligence and publishing.
US SMB Director of Strategy, Veeva
Rachel Belani has 16 years of experience in the pharmaceutical industry. She is currently a member of the global regulatory strategy team at Veeva, and serves as the US SMB director of strategy for the Veeva Vault Regulatory Information (RIM) product suite. In this role she contributes to the product’s direction, customer engagement, market adoption and strategic alliances. Before joining Veeva, Rachel’s career was focused on developing solutions and processes for life sciences organizations, with a specific focus on regulatory, clinical, and safety. She began her work inside the industry at Actelion Pharmaceuticals as the lead for regulatory and clinical processes and systems in the Americas. Following Actelion, Rachel transitioned into a series of consulting roles, helping life science companies define and optimize their business and solution architectures.
Head of Global Regulatory Informatics and Operations, PharmaLex
Timm joined PharmaLex in 2014 as Head of Global Regulatory Operations, where he is responsible for all world-wide electronic submission activities, regulatory information management and related topics. He is also leading and supporting process optimization projects within Regulatory Affairs as well as providing consultancy for Regulatory Information Management, IDMP-related topics, and eCTD publishing systems. Since 2020 Timm is also leading the Regulatory Affairs organization in the US.
Timm has more than 15 years of experience within Pharma R&D and about 10 years of experience within Regulatory Affairs. Previously he worked at Merck Serono heading the Dossier & Submission Management department and at Baxter, where he held several global positions in Biostatistics, Pharmacovigilance and R&D IT.